News for 'YMI' - (YM BioSciences Reports Fiscal 2012 Operational and Financial Results)
MISSISSAUGA, ON, Sep. 21, 2012, 2012 (Canada NewsWire via COMTEX) -- -
Completed dosing for 166 patient CYT387 Phase I/II nine-month trial -
- Completed enrolment of 61 patient CYT387 Phase II BID trial -
YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM), a drug development company
advancing hematology and cancer related products, today reported operational and
financial results for its 2012 fiscal year, ended June 30, 2012.
"We made significant progress with CYT387 during Fiscal 2012, highlighted by our
reporting at ASH 2011 of positive interim data that potentially differentiates
our drug from other JAK inhibitors. Leveraging these data, over the last several
months we conducted productive discussions with regulatory authorities in the US
and Europe which have affirmed the range of options available for the pivotal
program for CYT387," said Dr. Nick Glover, President and CEO of YM BioSciences.
"We continue to conduct a robust business development campaign aimed at
exploring potential opportunities to further develop and commercialize the drug
with other companies, seeking relationships that will focus on realizing the
broader commercial opportunity for CYT387."
Fiscal 2012 Highlights:
CYT387:
-- In December 2011, interim results for all 166 patients enrolled
in the Phase I/II trial were reported in a poster session at
ASH 2011. In this multicenter setting, CYT387 enabled more than
half of the patients with myelofibrosis who were initially
dependent on transfusions to become transfusion independent for
clinically relevant periods of time. CYT387 also continued to
produce significant and durable reductions of splenomegaly and
improvements of constitutional symptoms for many patients.
CYT387 was safe and well tolerated, with daily dosing up to and
exceeding two and a half years.
-- In June 2012, all eligible patients completed the core study of
the Phase I/II trial by receiving drug for nine months. These
patients are eligible to continue receiving drug in the ongoing
extension trial.
-- In July 2012, enrolment was completed for the complementary
Phase II BID (twice-daily dosing) trial of CYT387 initiated in
September 2011. This trial was designed to further explore the
range of potential dosing for CYT387 and recruited a total of
61 patients at six sites across North America. A review of
clinical data obtained across multiple doses and schedules
indicates that the optimal dose for CYT387 is 300mg given
once-daily. Additional findings from the BID study will augment
the data from the 166 patient Phase I/II study and facilitate
further investigation of the spleen, constitutional symptom and
anemia responses observed to date.
-- In mid-calendar 2012, meetings with US and European regulators
were conducted where potential pivotal Phase III clinical trial
designs to support marketing approval for CYT387 were
discussed. YM believes these discussions were productive,
confirming that several options were available for the pivotal
clinical development program of CYT387.
-- YM is exploring potential opportunities to further develop and
commercialize CYT387 with other companies, seeking
relationships that will focus on realizing the broader
commercial opportunity for CYT387 in myelofibrosis and beyond.
In February 2012, YM raised US$80.5 million, providing the
Company with flexibility to weigh any business development
opportunities that arise against the prospect of retaining full
control over commercial economics by advancing CYT387 further
into pivotal trials on its own.
CYT387 Next Steps:
-- Final nine-month data from the ongoing 166 patient Phase I/II
trial are expected to be reported by the end of calendar 2012.
-- Interim data from the extension trial, in which patients who
have completed the 166 patient Phase I/II trial are able to
continue long-term treatment with CYT387, are expected to be
reported by the end of calendar 2012.
-- Initial data from the Phase II BID trial are expected to be
reported by the end of calendar 2012.
-- Having reported positive interim data in December 2011 from a
166 patient Phase I/II trial of CYT387 in myelofibrosis, YM
conducted productive discussions with regulatory authorities in
the US and Europe which have affirmed the range of options
available for the pivotal program for CYT387. YM is now
preparing for pivotal trials under scenarios where the drug is
developed either with or without another company.
Nimotuzumab:
-- YM has been advised by Daiichi Sankyo Co., Ltd., CIMYM's
sub-licensee for nimotuzumab in Japan, that they are evaluating
the drug in a Phase II gastric cancer program together with
Kuhnil Pharma Co. Ltd., CIMYM's sub-licensee in South Korea,
and in a Phase II non-small cell lung cancer (NSCLC) program.
-- YM has been advised by Oncoscience AG (OSAG), CIMYM's
sub-licensee for Europe, that they are evaluating nimotuzumab
in Phase III glioma and pancreatic cancer programs.
-- YM has been advised by Innogene Kalbiotech PTE Ltd. (IGK), a
CIMYM sub-licensee, that they are evaluating nimotuzumab in
Phase II and III head and neck cancer programs and a Phase II
cervical cancer program.
CYT997:
-- A single-arm intravenous Phase Ib/II study in patients with
relapsed glioblastoma multiforme was closed to enrolment in
February 2011. Subsequent preclinical work was recently
completed involving the examination of repeated low doses of
CYT997, the envisioned optimal dosing regimen for this drug, in
a mouse breast cancer model. Based on the results obtained in
this preclinical model, in conjunction with the earlier
clinical trial data, YM has decided not to pursue further
clinical development of CYT997 at this time.
Summary Financial Results (CDN dollars) The interim consolidated financial
statements and comparative information for fiscal 2012 have been prepared in
accordance with International Financial Reporting Standards ("IFRS"). The
Company's Consolidated Financial Statements were previously prepared in
accordance with Canadian Generally Accepted Accounting Principles ("Canadian
GAAP").
Revenue, generated from out-licensing, for the fourth quarter of fiscal 2012
ended June 30, 2012 was $0.3 million compared with $0.2 million for the fourth
quarter of fiscal 2011. Revenue for fiscal 2012 of $1.1 million is comparable to
$1.0 million for fiscal 2011.
Net finance income was $2.2 million for the fourth quarter of fiscal 2012
compared to net finance costs of $0.5 million for the fourth quarter of fiscal
2011. Net finance income was $11.4 million for fiscal 2012 compared to net
finance costs of $10.3 million for fiscal 2011. The changes in net finance
income are primarily attributable to changes in the fair value adjustment for
USD warrants. Under IFRS, warrants denominated in a different currency than the
Company's functional currency must be classified as a financial liability and
measured at fair value, with changes reflected in profit or loss. For the fourth
quarter of fiscal 2012, the Company incurred a gain of $0.4 million on the
revaluation of warrants, compared to a loss of $0.8 million for the fourth
quarter of fiscal 2011. For fiscal 2012, the Company incurred a gain of $7.3
million on the revaluation of warrants, compared to a loss of $9.4 million for
fiscal 2011.
Licensing and product development expenses were $7.1 million for the fourth
quarter of fiscal 2012 compared with $7.4 million for the fourth quarter of
fiscal 2011. Licensing and product development expenses were $26.6 million for
fiscal 2012 compared with $23.8 million for fiscal 2011. Development expenses
for CYT387 increased due to the extension of the Phase I/II clinical trial in
myelofibrosis, start-up costs associated with the BID study, pre-clinical
development activities, and manufacturing of drug for these programs. Expenses
for nimotuzumab continued to decrease.
General and administrative expenses were $1.4 million for the fourth quarter of
fiscal 2012 compared to $1.2 million for the fourth quarter of fiscal 2011.
General and administrative expenses were $6.2 million for fiscal 2012 compared
to $7.7 million for fiscal 2011, primarily due to reduced salary expense after
the reorganization termination payments in fiscal 2011.
Net loss for the fourth quarter of fiscal 2012 was $6.1 million ($0.04 per
share) compared to $8.9 million ($0.08 per share) for the same period last year.
Net loss for fiscal 2012 was $20.3 million ($0.16 per share) compared to $40.9
million ($0.42 per share) for fiscal 2011.
As at June 30, 2012 the Company had cash and short-term deposits totaling $132.5
million and accounts payable and accrued liabilities totaling $3.1 million
compared to $79.7 million and $4.4 million respectively at June 30, 2011.
As at June 30, 2012 the Company had 157,546,793 common shares and 7,366,418
warrants outstanding.
Notice of Meeting: YM's Annual Meeting of Shareholders will be held on November
20, 2012, at 4:00 p.m. ET at the offices of Norton Rose OR LLP, Boardrooms A &
B, 38th Floor, 200 Bay Street, Royal Bank Plaza South Tower, Toronto, Ontario.
The management proxy circular documents and annual financial documents are
expected to be mailed to shareholders on October 8, 2012, and will be available
online at www.ymbiosciences.com, www.sec.gov and www.sedar.com.
About YM BioSciences YM BioSciences Inc. is a drug development company primarily
focused on advancing CYT387, an orally administered inhibitor of both the JAK1
and JAK2 kinases, which have been implicated in a number of hematological and
immune cell disorders including myeloproliferative neoplasms and inflammatory
diseases as well as certain cancers. Positive interim results have been reported
from a Phase I/II trial of CYT387 in 166 patients with myelofibrosis. YM's
portfolio also includes nimotuzumab, a humanized monoclonal antibody targeting
EGFR with an enhanced side-effect profile over currently marketed EGFR-targeting
antibodies. Nimotuzumab is being evaluated in numerous Phase II and III trials
worldwide. In addition, YM has several preclinical programs underway with
candidates from its library of novel compounds identified through internal
research conducted at YM BioSciences Australia.
This press release may contain forward-looking statements, which reflect the
Company's current expectation regarding future events. These forward-looking
statements involve risks and uncertainties that may cause actual results, events
or developments to be materially different from any future results, events or
developments expressed or implied by such forward-looking statements. Such
factors include, but are not limited to, changing market conditions, the
successful and timely completion of clinical studies, the establishment of
corporate alliances, the impact of competitive products and pricing, new product
development, uncertainties related to the regulatory approval process or the
ability to obtain drug product in sufficient quantity or at standards acceptable
to health regulatory authorities to complete clinical trials or to meet
commercial demand; and other risks detailed from time to time in the Company's
ongoing quarterly and annual reporting. Certain of the assumptions made in
preparing forward-looking statements include but are not limited to the
following: that CYT387 and nimotuzumab will generate positive efficacy and
safety data in ongoing and future clinical trials, and that YM as well as
CIMYM's various licensees will complete their respective clinical trials and
disclose data within the timelines communicated in this release. Except as
required by applicable securities laws, we undertake no obligation to publicly
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
YM BIOSCIENCES INC. Consolidated Statements of Financial Position (Expressed in
Canadian dollars, unless otherwise noted)
June 30, June 30, July 1,
2012 2011 2010
Assets
Current assets:
Cash and cash
equivalents $ 87,140,020 $ 32,046,630 $ 19,460,141
Short-term
deposits 45,310,288 47,611,922 26,184,991
Accounts
receivable 252,884 205,900 161,184
Prepaid
expenses 257,780 731,676 237,962
Total current
assets 132,960,972 80,596,128 46,044,278
Non-current
assets:
Property and
equipment 62,118 91,320 84,775
Intangible
assets 2,629,682 7,137,698 11,645,714
Total
non-current
assets 2,691,800 7,229,018 11,730,489
Total assets $ 135,652,772 $ 87,825,146 $ 57,774,767
Liabilities and
Equity
Current
liabilities:
Accounts
payable $ 803,421 $ 1,718,893 $ 699,277
Accrued
liabilities 2,262,972 2,652,511 2,085,824
Share
purchase
warrants 7,221,040 14,476,681 6,358,480
Deferred
revenue 381,270 594,072 1,523,916
Total current
liabilities 10,668,703 19,442,157 10,667,497
Non-current
liabilities:
Deferred
revenue 1,556,853 1,831,722 1,650,909
Total
non-current
liabilities 1,556,853 1,831,722 1,650,909
Equity:
Share
capital 340,173,078 264,548,643 203,498,239
Contributed
surplus 16,712,315 15,144,062 14,232,353
Deficit (233,458,177) (213,141,438) (172,274,231)
Total equity 123,427,216 66,551,267 45,456,361
Total
liabilities and
equity $ 135,652,772 $ 87,825,146 $ 57,774,767
YM BIOSCIENCES INC. Consolidated Statements of Loss and Comprehensive Loss
(Expressed in Canadian dollars, unless otherwise noted)
Years ended June 30, 2012 and
2011
2012 2011
Revenue:
Out-licensing $ 1,070,665 $ 1,033,239
1,070,665 1,033,239
Expenses:
Licensing and product
development 26,643,838 23,821,980
General and
administrative 6,175,132 7,739,857
32,818,970 31,561,837
Loss before financial
results (31,748,305) (30,528,598)
Finance income 11,431,566 480,314
Finance costs - (10,818,923)
Net loss and comprehensive
loss for the year $ (20,316,739) $ (40,867,207)
Basic and diluted loss per
common share $ (0.16) $ (0.42)
YM BIOSCIENCES INC. Consolidated Statements of Changes in Equity (Expressed in
Canadian dollars, unless otherwise noted)
Years ended June 30, 2012 and 2011
Share capital Contributed
Number Amount surplus Deficit Total
Balance, June
30, 2011 116,681,948 $ 264,548,643 $ 15,144,062 $ (213,141,438) $ 66,551,267
Net loss and
comprehensive
loss for the
year - - - (20,316,739) (20,316,739)
Transactions
with owners of
the Company,
recognized
directly in
equity:
Shares issued
pursuant to
prospectus
offering 40,250,000 74,232,207 - - 74,232,207
Shares issued
on exercise
of options 614,845 1,392,228 (670,529) - 721,699
Share-based
compensation - - 2,238,782 - 2,238,782
Total
transactions
with owners
of the
Company 40,864,845 75,624,435 1,568,253 - 77,192,688
Balance, June
30, 2012 157,546,793 $ 340,173,078 $ 16,712,315 $ (233,458,177) $ 123,427,216
Share capital Contributed
Number Amount surplus Deficit Total
Balance, July
1, 2010 80,359,623 $ 203,498,239 $ 14,232,353 $ (172,274,231) $ 45,456,361
Net loss and
comprehensive
loss for the
year - - - (40,867,207) (40,867,207)
Transactions
with owners of
the Company,
recognized
directly in
equity:
Shares issued
on exercise
of options 1,074,077 1,965,590 (798,279) - 1,167,311
Shares issued
on exercise
of warrants 723,248 2,375,179 - - 2,375,179
Shares issued
pursuant to
prospectus
offering 34,525,000 56,709,635 - - 56,709,635
Share-based
compensation - - 1,709,988 - 1,709,988
Total
transactions
with owners
of the
Company 36,322,325 61,050,404 911,709 - 61,962,113
Balance, June
30, 2011 116,681,948 $ 264,548,643 $ 15,144,062 $ (213,141,438) $ 66,551,267
YM BIOSCIENCES INC. Consolidated Statements of Cash Flows (Expressed in Canadian
dollars, unless otherwise noted)
Years ended June 30, 2012 and
2011
2012 2011
Cash provided by (used in):
Operating activities:
Net loss for the year $ (20,316,739) $ (40,867,207)
Items not involving cash:
Depreciation of property
and equipment 57,359 78,533
Amortization of
intangible assets 4,508,016 4,508,016
Interest income (716,799) (469,191)
Unrealized (gain) loss on
cash and cash
equivalents (1,269,907) 1,407,760
Gain on disposal of
property and equipment - (13,394)
Share-based
compensation 2,238,782 1,709,988
Change in fair value of
share purchase warrants (7,255,641) 9,411,162
Changes in non-cash working
capital balances:
Short-term deposits (598,996) (417,445)
Accounts receivable (46,984) (44,716)
Prepaid expenses 473,896 (493,714)
Accounts payable (915,472) 1,019,616
Accrued liabilities (389,539) 566,687
Deferred revenue (487,671) (749,031)
Net cash used in operating
activities (24,719,695) (24,352,936)
Investing activities:
Proceeds from sale of
short-term deposits 49,200,630 67,505,054
Purchase of short-term
deposits (46,300,000) (88,514,540)
Interest received 716,799 469,191
Additions to property and
equipment (28,157) (71,684)
Net cash provided by (used
in) investing activities 3,589,272 (20,611,979)
Financing activities:
Issuance of common shares
on exercise of options 721,699 1,167,311
Issue of common shares on
exercise of warrants &
